The Outcome of CPAP Titration Under Sleep Endoscopy

NCT ID: NCT03523013

Last Updated: 2020-09-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-01
• Study Completion Date: 2019-12-31

Brief Summary

The outcome of CPAP titration under sleep endoscopy: A randomized controlled crossover trial

Detailed Description

This is the study entitled "The outcome of CPAP titration under sleep endoscopy: A randomized controlled crossover trial". CPAP is first line golden standard treatment for Obstructive sleep apnea (OSA). However, the overall CPAP compliance is about 50%. One of the reasons responsible for the poor compliance is the inadequate pressure setting initially. Therefore, it is crucial for us to find out the adequate pressure as soon as possible. Sleep endoscopy is the way to evaluate upper airway obstruction of OSA patients. Meanwhile, the investigators used CPAP to titrate the adequate pressure to keep upper airway open under sleep endoscopy guidance. While the investigators find out this adequate pressure, the investigators set this pressure into CPAP program, which OSA patient will use for 1 month. To compare the different effect of CPAP under either auto-CPAP titration pressure or sleep endoscopy guidance pressure, those OSA patients will use auto-titration CPAP for 1 month as well. Another highlight of this study is the sedative agent-dexmedetomidine. Dexmedetomidine is a α2 antogonist, which cause patients sedative but less respiratory drive suppression. The mechanism of dexmedetomidine is more physiological for nature sleep.

Conditions

Obstructive Sleep Apnea; CPAP; DISE

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

CPAP pressure (determied by DISE)

Group Type: EXPERIMENTAL

CPAP

Intervention Type: DEVICE

CPAP treatment with different pressure for OSA patients

CPAP pressure (determined by physician)

Group Type: ACTIVE_COMPARATOR

CPAP

Intervention Type: DEVICE

CPAP treatment with different pressure for OSA patients

Interventions

CPAP

CPAP treatment with different pressure for OSA patients

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• moderate to severe OSA
• ESS >10

Exclusion Criteria

• ASA > 3
• allergy to Dexmedetomidine
• second or third degree AVB
• severe heart failure Fc class IV
• asthma acute attack

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chang Gung Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Division of Thoracic Medicine, Chang Gung Memorial Hospital

Taipei, , Taiwan

Countries

Taiwan

References

Wang TY, Huang YC, Lin TY, Ni YL, Lo YL. Outcome of CPAP Titration for Moderate-to-Severe OSA Under Drug-Induced Sleep Endoscopy: A Randomized Controlled Crossover Trial. Front Neurol. 2022 Jun 13;13:882465. doi: 10.3389/fneur.2022.882465. eCollection 2022.

Reference Type: DERIVED

PMID: 35769360 (View on PubMed)

Other Identifiers

201701422A3

Identifier Type: -

Identifier Source: org_study_id